Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap WITHDRAWAL OF INDIVIDUAL 0.3 mL DOSES. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and also includes information about the U.S. Food and Drug Administration (FDA)-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA) for use in individuals 12 years of age and older9. The safety of the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 12 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. The AAP is dedicated to the health of all children and the pediatric professionals who care for them. WHAT YOU NEED TO KNOW BEFORE YOU GET ANY OF THESE VACCINES. February 15, 2023: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GlaxoSmithKline LLCs monoclonal antibody, sotrovimab, from 24 months to 30 months. Check Expiry. Get the latest news from the AAP including press statements, the AAP Voices Blog, the Pediatrics OnCall Podcast and more! From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. helix-grid, helix-mega-menu, helix-layout-container, helix-core-grid, helix-core-header, helix-core-page-break, helix-core-card-group, helix-core-footer, helix-core-band { Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc. Expiry Checker: Janssen COVID-19 Vaccine Under Emergency Use Authorization. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. See "MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements. The Office of Counterterrorism and Emerging Threats (OCET) collaborates with FDA Centers and federal partners to facilitate access to MCMs. An additional 1 DuoDote lot is no longer useable and should be properly disposed of. To learn more about this program, visit http://www.hrsa.gov/cicp/ or call 1-855-266-2427. This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 104 for Evusheld. November 26, 2019: This posting and FDAs November 18, 2019, memorandum (PDF, 230 KB) provide expiration dating updates for health care professionals and emergency responders for certain lots of MMT AtroPen (atropine), CANA (diazepam), DuoDote, Morphine Sulfate, and Pralidoxime Chloride auto-injectors for use during nerve agent emergencies. FDA Fact Sheet for Health Care Providers Administering Vaccine (5 through 11 years), BIVALENT (Original and Omicron) CDC US COVID-19 Vaccine Product InformationCDC Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines. 'g}/kM&Mg The higher frequency of reported unsolicited non-serious adverse events among Pfizer-BioNTech COVID-19 Vaccine recipients compared to placebo recipients was primarily attributed to local and systemic adverse events reported during the first 7 days following vaccination that are consistent with adverse reactions solicited among participants in the reactogenicity subset and presented in Tables 3 and 4. Read below to find the specifics on COVID-19 vaccine storage and expiry. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea. The extended expiration date is effective immediately for all currently available batches that have not yet expired. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time).Thawed vaccine cannot be refrozen. 1 0 obj Fierce Life Sciences Events. |/FWjSZl;u!hU$xO=6 :sfuoHDZ-Uqw&+q;#"To-C*HRgZ^lw?BG:+Y7ZBJnw{%8q|\TM|tiv zGjt7e Storage for longer than 10 weeks requires an Ultra Cold freezer. No. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. Count out 18 months, using the month printed on the vial as month 1. Visually inspect each dose in the dosing syringe prior to administration. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines This product (for ages 12 years and older) is no longer being distributed. No. Created Date: 12/3/2021 11:57:01 AM . July 29, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 18 months to 24 months. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer.Thawed vaccine cannot be refrozen. September 6, 2022: FDA and HHS/ASPR authorized an extension to the shelf life from 12 months to 18 months for certain lots of the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use). Study BNT162-01 (Study 1) was a Phase 1/2, 2-part, dose-escalation trial that enrolled 60 participants, 18 through 55 years of age. The extended expiry date for each lot can be found in Table 1 below. visibility: hidden; Among the 59 patients who had been seronegative before the third dose, 26 (44%) were seropositive at 4 weeks after the third dose. Patients should still be counselled to maintain physical precautions to help prevent COVID-19. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.38 MB) and the Letter of Authorization (PDF, 488 KB). In Study 2, an analysis of SARS-CoV-2 50% neutralizing titers (NT50) 1 month after Dose 2 in a randomly selected subset of participants demonstrated non-inferior immune responses (within 1.5-fold) comparing adolescents 12 through 15 years of age to participants 16 through 25 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2 (Table 10). HWrF+H, rZRJlqI)B@EE4zzz^^8|.II_x2Mi4eYrv[n^IL#NLI{owb7'g^[ g|\Z0dF]/QXbFL@UWu7ZSV8l9'caP)gpSL^: ]N]?2W7A(&5#4?&QFb:h\Q9ov?v FReZG+,LGe[pHv2nK::pWF[lmGd-G^1O'DxpZJj/k9s#a_dMv."&| In a similar analysis, in participants 56 years of age and older (Pfizer-BioNTech COVID-19 Vaccine = 7,960, placebo = 7,934), serious adverse events were reported by 0.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.6% of placebo recipients who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. AAP original research, including a robust practice-based research network, addresses important questions regarding pediatric practice and the health and well being of children. Vials stored at -25C to -15C (-13F to 5F) for up to 2 weeks may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). 2 0 obj If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial. The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness 2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days) for adolescents in the Pfizer-BioNTech COVID-19 Vaccine group. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in participants 12 years of age and older. In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents (1,131 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 1,129 placebo) were 12 through 15 years of age. If not stored between -90C to -60C (-130F to -76F), vials may be stored at -25C to -15C (-13F to 5F) for up to 2 weeks. The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including these vaccines. Establishing clear standard operating procedures (SOPs) for COVID-19 vaccine storage, handling, and administration to minimize vaccine waste. For primary vaccination, another choice for preventing COVID-19 is SPIKEVAX (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. See Overall Safety Summary (Section 6) for additional information. You are being offered either COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. 1-800-666-7248. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown below; as long as approved storage conditions have been maintained. COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved vaccines to prevent COVID-19 caused by SARS-CoV-2. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time. It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination with the Pfizer-BioNTech COVID-19 Vaccine. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. IuaPmrE&n-W.2Icy^&PM | ,5A^D|"c%&g;'hy,/A Hr|G,,NNS!YFcZ. Count out 18 months, using the month printed on the vial as month 1. For example, if the manufacture date is August 2021 (8/21), include August as one of the 12 months; the expiration date will be January 2023 (1/31/23). The prevalence of anti-SARS-CoV-2 antibodies was 68% (67 of 99 patients) 4 weeks after the third dose. When you get your first COVID-19 vaccine, you will get a vaccination card. Across both age groups, 18 through 55 years of age and 56 years of age and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group. 2C to 8C (36F to 46F)Unpunctured vials until the expiration date Do not freeze. As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 below). display: contents; While this is important to ensure patient safety, it also means that the MCMs, some of which might still be stable, must be replaced regularly, which can be very costly. NDC#: 59267-1055-4 . As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the "Vaccine Information Fact Sheet for Recipients and Caregivers" (and provide a copy or direct the individual to the website www.cvdvaccine.com to obtain the Vaccine Information Fact Sheet for Recipients and Caregivers) prior to the individual receiving each dose of the Pfizer-BioNTech COVID-19 Vaccine, including: For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov. Should you decide not to receive any of these vaccines, it will not change your standard medical care. Signs of a severe allergic reaction can include: Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine, more commonly in adolescent males and adult males under 40 years of age than among females and older males. To access the most recent Pfizer-BioNTech COVID-19 Vaccine Fact Sheets, please scan the QR code provided below. * Sections or subsections omitted from the full emergency use authorization prescribing information are not listed. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Tamiflu capsules, provided that the products have been stored under labeled storage conditions. Please note: the ultra-cold temperature range has been broadened to include-90 C (-130F). Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine [see Description (13)]. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. The Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Lot Number and Expiration Date Report is available to public health, healthcare, and pharmacy organizations located within the United States for vaccine administration, inventory, and reporting purposes. As soon as you land on the tool page, You will have to enter 2 things. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Know your Vaccine Products and Storage Needs, Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States, Long-term Follow-up Care for Childhood, Adolescent and Young Adult Cancer Survivors, Roadmap for Care of Cancer Survivors: Joint Report Updates Recommendations, American Academy of Pediatrics Offers Guidance for Caring and Treatment of Long-Term Cancer Survivors, Childhood Cancer Survivors: What to Expect After Treatment, Transition Plan: Advancing Child Health in the Biden-Harris Administration, Childrens Health Care Coverage Fact Sheets, Prep- Pediatric Review and Education Programs, Practice Research in the Office Setting (PROS), Pediatrician Life and Career Experience Study (PLACES), CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov), Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov), Fact Sheet for Health Care Providers Administering Vaccine (5 11 years), CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary, Pfizer-BioNTech COVID-19 Vaccine (Gray Cap) Age 12 and Over, Fact Sheet for Health Care Providers Administering Vaccine (12 years and up), FDA Fact Sheet for Health Care Providers Administering Vaccine (5 through 11 years), BIVALENT (Original and Omicron), CDC US COVID-19 Vaccine Product Information, CDC Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines, Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Moderna COVID-19 Vaccine Storage and Handling Summary, Fact Sheet for Health Care Providers Administering Vaccine (6 months 5 years), Fact Sheet for Health Care Providers Administering Vaccine (6 11 years). For those doses that are close to expiry, if they are being held under appropriate conditions for ensuring their integrity for use, they can potentially be quarantined to see if data on new stability studies warrant extension of the initial expiry date according to appropriate policies and procedures. Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a purple cap is authorized for use to provide: COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech that is indicated for active immunization to prevent COVID-19 in individuals 12 years of age and older. Vaccine expires 18 months after the manufacture date. For example, if the manufacture date is August 2021 (8/21), include August as one of the 12 months; the expiration . Please see the, Table 1:Study 2 Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 Through 55 Years of Age, Table 2: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 Through 55 Years of Age, Table 3: Study 2 Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 56 Years of Age and Older Reactogenicity Subset of the Safety Population, Table 4: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 56 Years of Age and Older Reactogenicity Subset of the Safety Population, (Kamar N, Abravanel F, Marion O, et al. Overall in a similar analysis in which 7960 participants 56 years of age and older received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in 23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the placebo group, for participants who received at least 1 dose. of Insurance Complaint Resource, Creating Health: Lifestyle & Weight Management, Diabetes Self-Management Education (DSME), NCPA Innovation Center/ CPESN Community Pharmacy Fellowship. You should not get any of these vaccines if you: WHAT ARE THE INGREDIENTS IN THESE VACCINES? N Engl J Med), in 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 978 months previously who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported in recipients who were followed for 1 month following post Dose 3. In Study 2 in which 10,841 participants 16 through 55 years of age received Pfizer-BioNTech COVID-19 Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported in 29.3% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the placebo group, for participants who received at least 1 dose. FDAs Office of Regulatory Affairs (ORA) Field Science Laboratories centrally manages the program, including interacting with DoD and coordinating laboratory work. As required by the EUA, of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab), must be stored under refrigerated temperature at 2C to 8C (36F to 46F) in the original carton to protect from light. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. For further assistance with reporting to VAERS, call 1-800-822-7967. In 2018, FDA approved TPOXX (tecovirimat) for treatment of smallpox in adults and children. HOW ARE COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT RELATED? The Pfizer-BioNTech and Moderna COVID-19 vaccines both have a shelf life of up to six months, but Pfizer's requires ultra-cold storage to last that long, the company said in November. Please refer to the table on this page for updates. July 26, 2022 When FDA first issued the EUA authorizing Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), it established a 12-month product shelf-life. The safety population includes participants 16 years of age and older enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020. The vaccine is administered as a 2-dose series, 3 weeks apart. Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).